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Notice2025-192812025-10-02

Pediatric Advisory Committee (PAC); Notice of Meeting; Establishment of a Public Docket; Request for Comments

Health and Human Services Department, Food and Drug Administration

Abstract

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Pediatric Advisory Committee (PAC). The general function of the Committee is to provide advice and recommendations to FDA on pediatric regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.

Action & Dates

Action
Notice; establishment of a public docket; request for comments.
Dates
The meeting will be held on virtually on November 13, 2025, from 10:00 a.m. to 4:00 p.m. Eastern Time (ET).

Document Excerpt

Document Headings Document headings vary by document type but may contain the following: the agency or agencies that issued and signed a document the number of the CFR title and the number of each part the document amends, proposes to amend, or is directly related to the agency docket number / agency internal file number the RIN which identifies each regulatory action listed in the Unified Agenda of Federal Regulatory and Deregulatory Actions See the Document Drafting Handbook for more details. Department of Health and Human Services Food and Drug Administration [Docket No: FDA-2025-N-3774] AGENCY: Food and Drug Administration, HHS. ACTION: Notice; establishment of a public docket; request for comments. SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Pediatric Advisory Committee (PAC). The general function of the Committee is to provide advice and recommendations to FDA on pediatric regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document. ( printed page 47777) DATES: The meeting will be held on virtually on November 13, 2025, from 10:00 a.m. to 4:00 p.m. Eastern Time (ET). ADDRESSES: All meeting participants will be heard, viewed, captioned, and recorded for this advisory committee meeting via an online teleconferencing and/or video conferencing platform. Answers to commonly asked questions about FDA advisory committee meetings, may be accessed at https://www.fda.gov/​AdvisoryCommittees/​AboutAdvisoryCommittees/​ucm408555.htm . FDA is establishing a docket for public comment on this meeting. The docket number is FDA-2025-N-1246. The docket will close on November 12, 2025. Submit either electronic or written comments on this public meeting on or before November 12, 2025. Please note that late, untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments u

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Full Document

Citation: 90 FR 47776